阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531052941051681051601050231048601051010.16
210.551049241048291048760.07
单位质量响应值RSD%判断
9981.109940.850.29数据可信
长期6月-供试品溶液-2023111721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12435-24352.1932.4729.372.192.4729.39
22464-24642.2202.22
32929-29292.6382.64
42882-28822.5962.60
54080-40803.6753.68
61639-16391.4761.48
10min16237-62375.6185.8016.225.635.8116.29
26686-66866.0236.04
35903-59035.3185.33
47056-70566.3566.37
57887-78877.1057.13
64835-48354.3554.36
15min18676-86767.8168.0810.817.868.1210.89
29394-93948.4628.51
38668-86687.8087.85
49643-96438.6878.74
510076-100769.0779.14
67339-73396.6116.64
20min110554-105549.5079.858.889.599.948.93
211145-1114510.04010.13
310711-107119.6499.74
412026-1202610.83310.93
511835-1183510.66110.77
69361-93618.4338.50
30min112476-1247611.23911.405.0011.3811.545.09
213136-1313611.83311.98
312518-1251811.27611.42
413097-1309711.79811.96
513158-1315811.85312.02
611528-1152810.38510.50
45min114058-1405812.66412.702.9712.8712.923.10
214117-1411712.71712.93
314068-1406812.67312.88
414555-1455513.11113.34
514454-1445413.02013.26
613364-1336412.03912.21
60min114798-1479813.33013.462.7913.6013.742.89
215186-1518613.68013.96
314820-1482013.35013.62
415247-1524713.73514.03
515367-1536713.84314.15
614237-1423712.82513.07
极限115492-1549213.95514.041.4914.3014.391.59
215525-1552513.98514.35
315316-1531613.79714.15
415911-1591114.33314.71
515817-1581714.24814.63
615433-1543313.90214.21
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531048141047751046051046281045741046790.11
210.551038901039741039320.06
单位质量响应值RSD%判断
9941.039851.370.65数据可信
长期6月-供试品溶液-2023111821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15764-57645.2265.5928.005.235.5928.02
27518-75186.8176.82
37818-78187.0897.09
46414-64145.8165.82
53002-30022.7222.72
66445-64455.8445.84
10min18052-80527.3017.165.717.337.195.61
27798-77987.0717.11
38161-81617.4007.44
47118-71186.4546.49
58444-84447.6567.67
67815-78157.0867.12
15min19759-97598.8498.742.998.928.812.92
29402-94028.5258.60
39584-95848.6908.77
49275-92758.4108.48
510090-100909.1499.21
69694-96948.7908.86
20min111602-1160210.52010.213.4410.6410.333.35
211281-1128110.22910.35
311022-110229.99410.12
410687-106879.6909.81
511751-1175110.65510.76
611210-1121010.16410.29
30min113233-1323311.99912.022.1912.1812.192.17
213046-1304611.82912.01
313547-1354712.28312.47
412998-1299811.78611.95
513664-1366412.39012.56
613017-1301711.80311.98
45min114864-1486413.47813.341.9613.7213.581.94
214752-1475213.37613.62
314956-1495613.56113.81
414321-1432112.98513.22
514996-1499613.59713.83
614403-1440313.06013.30
60min115462-1546214.02014.061.9014.3414.381.87
215424-1542413.98514.31
315859-1585914.38014.71
415838-1583814.36114.67
515093-1509313.68514.00
615381-1538113.94614.26
极限115983-1598314.49214.512.3214.8914.902.26
215748-1574814.27914.68
316079-1607914.57914.99
415989-1598914.49814.88
515560-1556014.10914.50
616650-1665015.09715.49
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531048081048551047411047651047541047850.05
210.551040621040361040490.02
单位质量响应值RSD%判断
9951.099862.460.64数据可信
长期6月-供试品溶液-2023111921批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13050-30502.7633.3311.002.763.3211.01
23827-38273.4663.47
33675-36753.3293.33
44287-42873.8833.88
53680-36803.3333.33
63510-35103.1793.18
10min15947-59475.3875.946.805.405.966.82
27243-72436.5606.58
36712-67126.0796.10
46553-65535.9355.96
56682-66826.0526.07
66221-62215.6355.65
15min18649-86497.8348.133.447.888.183.48
29506-95068.6108.67
38903-89038.0648.12
48982-89828.1368.19
59095-90958.2388.29
68717-87177.8967.94
20min113522-1352212.24810.708.6612.3410.808.55
211485-1148510.40310.51
310820-108209.8009.90
410820-108209.8009.90
512257-1225711.10211.20
611960-1196010.83310.93
30min112718-1271811.51911.671.0511.6811.821.03
212972-1297211.75011.91
312757-1275711.55511.71
412810-1281011.60311.76
512974-1297411.75111.91
613045-1304511.81611.97
45min114299-1429912.95113.032.4213.1713.252.40
214350-1435012.99813.22
314326-1432612.97613.19
414177-1417712.84113.06
515064-1506413.64413.87
614085-1408512.75812.98
60min115163-1516313.73413.832.4614.0314.122.42
215167-1516713.73814.04
315726-1572614.24414.53
414950-1495013.54113.83
515733-1573314.25014.55
614877-1487713.47513.76
极限115426-1542613.97214.081.2514.3414.461.25
215904-1590414.40514.78
315426-1542613.97214.34
415395-1539513.94414.31
515628-1562814.15514.54
615523-1552314.06014.42
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.531044361044181043691044281043491044000.04
210.551061261059721060490.11
单位质量响应值RSD%判断
9914.5310052.040.98数据可信
长期6月-供试品溶液批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12661-26612.3922.336.982.392.337.09
22297-22972.0652.06
32471-24712.2212.22
42727-27272.4512.45
52788-27882.5062.51
62624-26242.3592.36
10min17062-70626.3486.244.696.366.254.66
26390-63905.7445.76
36853-68536.1606.17
47355-73556.6116.62
56885-68856.1896.20
67113-71136.3936.41
15min19493-94938.5338.802.748.588.852.73
29495-94958.5358.58
310016-100169.0039.05
49869-98698.8718.92
59730-97308.7468.79
610141-101419.1159.16
20min111406-1140610.25210.431.5910.3510.521.60
211458-1145810.29910.39
311499-1149910.33610.43
411749-1174910.56110.66
511882-1188210.68010.78
611616-1161610.44110.54
30min113135-1313511.80612.152.7011.9612.302.68
213176-1317611.84311.99
314146-1414612.71512.87
413522-1352212.15412.31
513507-1350712.14112.30
613597-1359712.22212.38
45min114700-1470013.21313.451.5813.4313.681.56
214922-1492213.41313.63
315235-1523513.69413.92
414741-1474113.25013.48
515253-1525313.71013.93
614942-1494213.43113.66
60min115719-1571914.12914.121.7114.4214.411.68
215749-1574914.15614.44
316099-1609914.47114.77
415398-1539813.84014.14
515414-1541413.85514.15
615850-1585014.24714.55
极限115604-1560414.02614.443.7114.4014.823.58
217241-1724115.49715.86
315814-1581414.21414.60
415801-1580114.20314.58
516097-1609714.46914.85
615855-1585514.25114.63
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